The present invention relates to an antiseptic lubricant composition for use in sexual relations. The lubricant composition of this invention reduces the risk of infection by viruses such as herpes simplex (HSC), cytomegalovirus (CMB), influenza A, parainfluenza, hepatitis B (HBV) and particularly human immunodeficiency virus (HIV). The lubricant composition of this invention, in addition to destroying bacteria and viruses, prevents pregnancy by destroying sperm cells and furthermore prevents any surviving sperm cells from entering the uterus. The present invention also relates to a method for reducing the risk of infection by lethal viruses during sexual relations and reducing the risk of pregnancy, and to devices containing antiseptic lubricant.
In the last decade, the rapid spread of the HIV and the accompanying concern of its terrifying consequences for mankind, have created a sense of urgency to find both short and long term solutions for this modern plague. There are many ways in which the HIV and some other viruses are transmitted by people. One of the most common forms of transmission is by sexual contact. During intercourse, there are basically three ways in which the HIV can be transmitted from one person to another. One way is by the friction caused by a penis penetrating into the vagina, which is capable of tearing small and sometimes invisible blood vessels (capillary vessels) of both sexual partners. The blood from these vessels is consequently commingled and the HIV present in one partner is transferred via the blood to the other partner. As far as is known, the HIV develops mainly in the blood cells, although it is transferred and transmitted by body fluids. A second way for transmitting the HIV is through the body fluids which the body secretes during sexual relations. A third way is via the semen. It has been found that the HIV can reside in the spermatophore (sperm-liquid) or even on or in the spermatocide (sperm cell). Thus, the HIV which resides in the sperm may infect the other sexual partner.
HIV, herpes and similar viruses are surrounded by three envelopes. These envelopes are composed of the same material as that of the human cell walls. When the outside envelope of the virus comes into contact with the outer cell wall of humans, the human cell recognizes the virus as part of itself and absorbs it, and proceeds to produce more viruses until they overflow. The excess viruses are then expelled from the human cell and search for other host cells which will continue to produce more viruses.
The most common and so far most effective way of avoiding infection by HIV and other related viruses during sexual relations is by the use of a condom put on prior to copulation. The condom prevents direct contact between sexual organs and body fluids of the partners and also retains the sperm and prevents it from entering the vagina and eventually the uterus. As far as is known, the HIV cannot penetrate the rubber material from which condoms are made. Only if the condom is defective, for example perforated or otherwise damaged, can transmission of the virus occur. Many people, however, do not like using a condom, mainly because of the odd sensation of indirect contact with the sex partner, which in many cases interferes with and/or diminishes sexual satisfaction. It is also known that to reduce friction and increase sexual satisfaction during intercourse, people avail themselves of lubricants which may be soluble, like K-Y (a Trademark product Johnson & Johnson) or a non-soluble fatty lubricant, like soft paraffin. This is particularly the case with atrophy and in elderly people, who use lubricants to complement the diminished quantities of natural lubricants produced as compared with the situation in younger people.
Gels and foams for application before or during sexual intercourse are known, some of which contain spermicides, such as Nonoxynol-9. Many disinfectants are also known to be effective against viruses and are used as antiseptics in topical applications in concentrations that are not harmful to body tissues. Among the known disinfectants are the previously mentioned Nonoxynol-9, as well as Benzalkonium Chloride, Povidone Iodine, Nitrofurazone and chlorhexidine salt. These disinfectants, and others not mentioned but found in medical pharmacopoeias, have similar disinfecting characteristics, although they differ chemically and react differently to body tissues. The disinfectant compositions are generally used as antiseptics and applied topically for destroying bacteria and/or viruses that already exist in the area to which they are applied and to maintain these areas free of such organisms, to prevent possible future infections such as in the treatment of wounds and burns. Some compositions containing disinfectants are also known for use in disinfecting the sexual organs. These disinfectants, however, have not been successful in preventing HIV infections resulting from sexual relations. It was known to those in the field, that merely applying an antiseptic, that is effective against HIV in topical applications, to the sexual organs during sexual relations does not prevent HIV infection. In a study by J. Kreiss et. al, JAMA 268: 4, 477-82, Jul. 22-29, 1992, nonoxynol-9, a well known antiseptic spermicide, was tested in Nairobi prostitutes for use in preventing heterosexual transmission of HIV. Although nonoxynol-9 is known to be quite effective in killing HIV topically, it did not prevent HIV transmission when used as contraceptive, i.e. during sexual relations. Thus there appears to be a clear difference between topical activity against HIV and actual prevention of transmission of HIV during sexual relations.
U.S. Pat. No. 4,602,042 to Chantler, et al. claims a contraceptive method comprising applying to the mucus in the vagina a spermicidal compound such as chlorhexidine.
M. A. Harbison, et al. in J. ACQUIR. IMMUN. DEFIC. SYNDR. Vol 2, no. 1, 1989, pages 16-20, demonstrated topical decontamination and deactivation of HIV in cell culture systems with antiseptic compounds such as Betadine and chlorhexidine glucagon in dilute solutions. Among the many compositions tested topically against HIV there was a single gel composition containing Betadine antiseptic which was effective only at a much higher concentration of Betadine than ordinary solutions containing this antiseptic. Harbison, et al., although showing that these antiseptic materials are effective against HIV when applied topically, does not suggest a prophylactic spermicidal lubricating composition for use during sexual relations. U.S. Pat. No. 5,342,617 to Gold discloses a water based lubricant composition for application, inter alia, in the vagina. The composition is bases on high molecular weight polyethylene oxides in combination with polyhydroxy humectants. This lubricating base composition is the essence of Gold's disclosure. In order to prevent bacterial, mold or fungal growth in the humectant, stabilizers or sterilizing inhibitors are added, i.e. to protect the composition from deteriorating and prolong its shelf life. Parabens were particularly preferred for this purpose. The patent also mentions, by the way, that spermicides may be added to the composition to inhibit pregnancy. However, no spermicides were listed, exemplified or claimed, nor were any effective concentration of these suggested.